UPDATE: August 27, 2020: CMS Administrator Seema Verma late Wednesday responded to Healthcare Dive's article on Twitter, contending the agency is "not delaying the Stark rule and is working hard to finalize it." However, CMS did push back the publication deadline for the final rule, as now it won't be published by August 2020 as previously spelled out in the Spring regulatory agenda. CMS is giving itself more time to finalize the rule.
The American Hospital Association censured the delay in a Wednesday statement. "This is an extremely disappointing setback for hospital and health system efforts to continue to innovate coordinated care arrangements," AHA General Counsel Melina Hatton said. "We strongly urge CMS to move more quickly to finalize these improvements."
- CMS has pushed back publishing a final rule that would ease anti-kickback regulations on providers by a year. The move is likely to anger healthcare organizations that have long clamored for the rule's relaxation.
- The deadline to finalize the rule proposed Oct. 17, 2019, is now Aug. 31, 2021. Originally, the rule relaxing stipulations of the decades-old Stark Law was expected this month. It's unclear how the extension affects OIG's tandem rule slacking similar regulations outlined in the Federal Anti-Kickback Statute and the Civil Monetary Penalties Law.
- CMS chalked up the delay to the need to detangle the many thorny issues raised by healthcare companies in their comments on the rule. "We are still working through the complexity of the issues raised by comments received on the proposed rule and therefore we are not able to meet the announced publication target date," Wilma Robinson, HHS deputy executive secretary, wrote in a notice on the change dated Monday. CMS did not respond to requests to clarify what issues are tying up the rule.
Hospital groups are unlikely to be pleased with the delay. The American Hospital Association earlier this month sent the Office of Management and Budget a letter urging them to expedite the review and release of the final Stark and AKS regulations.
"These rules take on even more significance in light of the COVID-19 pandemic," AHA EVP Thomas Nickels wrote in the letter dated Aug. 19. "These rules will remove unnecessary regulatory burden from hospitals and health systems, allow for enhanced care coordination for patients, improve quality, and reduce waste in the Medicare and Medicaid programs."
AHA did not respond to a request for comment by time of publication.
Healthcare organizations have said the Stark Law and Anti-Kickback Statute, passed decades ago in an attempt to deter physicians from referring patients to other locations or for services that would financially benefit them, are outdated and burdensome. Providers say the proposed changes are long overdue, citing longstanding concerns the laws hinder efforts to coordinate patient care across different sites and episodes.
The proposed rule, if finalized, would sharply ease federal anti-kickback regulations in a bid to help providers use value-based payment arrangements, reflecting the growing shift away from fee-for-service reimbursement and siloed care models.
The rule clarified exemptions from the physician self-referral law for certain value-based payment arrangements among physicians, providers and suppliers. Specifically, it applies to models with a specific patient population, where one of the entities takes on full financial risk for providing Medicare Part A and Part B for the first six months. The payments can either be capitated or global.
Doctors would be required to pay back a fourth of payments if they don't meet financial goals.
The proposed rule also introduced a new exemption for certain arrangements under which a doctor receives limited payment for items and services that he or she provides, and another that would allow hospitals and medical device manufacturers to donate cybersecurity tools and other related software to doctors without fear of retribution.
Comments on the proposed rule from the hospital and physician community were generally supportive of the changes, though some organizations, including the American Hospital Association and Walmart, thought the feds didn't go far enough. Hospital groups argued the exceptions should be expanded to include private payers, along with Medicare and Medicaid and the definition of value-based arrangements should be broadened, along with some other clarifications.
Per the Social Security Act, agencies have to maintain a regular timeline for publishing final regulations, normally within three years of the draft. However, they are allowed to extend the original deadline, if they justify the change.
Shannon Muchmore contributed to this story.